Systems and methods for communicating through a hard plastic mask

ABSTRACT

The present disclosure relates generally to providing a flexible patch and system for communicating through hard plastic masks such as CPAP/BiPAP® masks. Using electronic circuitry and novel designs, the present systems and methods can detect speech vibrations and output audible speech from hard plastic mask wearers. For example, in certain embodiments, the present systems and methods can recognize speech through a CPAP/BiPAP® mask, filter out non-human voice related noise, and output the resulting speech of the mask wearer.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of and priority to U.S. ProvisionalPatent Application No. 62/878,083, filed Jul. 24, 2019, entitled “Maskwith Incorporated Communication Aid and Diagnostic Aid Feature forCommunication Aid,” and is a continuation-in-part application of U.S.patent application Ser. No. 16/895,845, entitled “Systems and Methodsfor Communicating Through a Hard Plastic Mask,” filed Jun. 8, 2020,which is a continuation-in-part of:

U.S. patent application Ser. No. 29/727,217, entitled “CommunicationDevice for Hard Plastic Masks,” filed Mar. 9, 2020, which is acontinuation of U.S. patent application Ser. No. 29/699,450, entitled“Communication Device for Hard Plastic Masks,” filed Jul. 25, 2019,which is a continuation-in-part application of U.S. patent applicationSer. No. 16/161,914, filed Oct. 16, 2018, entitled “Systems and Methodsfor Communicating Through a Hard Plastic Mask,” which is a continuationof U.S. Non-Provisional patent application Ser. No. 15/961,509, filedApr. 24, 2018, entitled “Systems and Methods for Communicating Through aHard Plastic Mask,” now U.S. Pat. No. 10,136,225, which claims thebenefit of and priority to U.S. Provisional Patent Application No.62/572,023, filed Oct. 13, 2017, entitled “Communication System for HardPlastic Masks,” and U.S. Provisional Patent Application No. 62/489,370,filed Apr. 24, 2017, entitled “Communication Device for Non-InvasiveVentilation Masks;” and

U.S. patent application Ser. No. 16/161,914, filed Oct. 16, 2018,entitled “Systems and Methods for Communicating Through a Hard PlasticMask,” which is a continuation of U.S. Non-Provisional patentapplication Ser. No. 15/961,509, filed Apr. 24, 2018, entitled “Systemsand Methods for Communicating Through a Hard Plastic Mask,” now U.S.Pat. No. 10,136,225, which claims the benefit of and priority to U.S.Provisional Patent Application No. 62/572,023, filed Oct. 13, 2017,entitled “Communication System for Hard Plastic Masks,” and U.S.Provisional Patent Application No. 62/489,370, filed Apr. 24, 2017,entitled “Communication Device for Non-Invasive Ventilation Masks,” allof the above are hereby incorporated by reference herein as if set forthin their entireties.

TECHNICAL FIELD

The present systems and methods relate generally to communicatingthrough a hard plastic mask.

BACKGROUND

Currently, in critical care settings, patients that experience acuterespiratory distress are prescribed noninvasive ventilation (“NIV”).This form of ventilation keeps the patient conscious, and a hard plasticmask is placed over their nose and mouth supplying positive pressure tothe patient's respiratory system to aid in their breathing. Due to thefragility of the patient's state, the patient cannot remove the maskwithout risk of severe and immediate complications. This may lead to apatient who is completely unable to communicate with the outside worldbecause of the sound barrier created by the hard plastic mask.

The communication barrier may create a host of problems. In many cases,a medical professional's best means of coming to a quick and accuratediagnosis is to be able to understand the patient's medical history,which is typically communicated to them by the patient or a familymember of the patient. However, without a family member present and thepatient wearing a mask, a doctor or nurse may not be able to get thisvital information. The patient also may experience feelings ofclaustrophobia and isolation, causing them to try and remove the mask.This may lead to less effective treatment because medical professionalsmay have to correct the patient's treatment multiple times.

Currently, patients may communicate medical history and complaints tothe medical staff by using communication boards. These boards have twoto three dozen pictures, which are sometimes unlabeled, and an alphabetso that the patient typically can point to the most applicable pictureor spell out a customized message. With NIV becoming more common, thereis a long-felt but unresolved need for a system or method that canfacilitate a more effective and natural means of patient communicationwith the outside world through a hard plastic mask.

BRIEF SUMMARY OF THE DISCLOSURE

Briefly described, and according to one embodiment, aspects of thepresent disclosure generally relate to systems and methods forrecognizing speech vibrations through hard plastic masks, filtering outnon-human voice related noise, and outputting the resulting speech ofthe mask wearer.

In various embodiments, the broad purpose of the systems and methodsdisclosed herein is to allow patients that are required to wear hardplastic masks, such as CPAP/BiPAP® masks, to be able to talk to theoutside world without taking off the mask or inhibiting the currenttherapy that the mask is supplying. Many aspects of the present systemsand methods include several components. In a particular embodiment, thesystem includes 1) a microphone element (e.g., piezoelectric element)that can be integrated with the mask during or after production of themask, and either within or on the outside of the material of the mask;2) a system for amplifying a signal received from the microphone (e.g.,piezoelectric) element through a wired or wireless connection; 3) aconnection to a built-in speaker system (the speaker system may beexternal to an amplification system) or to a database. As will beunderstood from discussions herein, the wired signal can be transmitteda number of ways, many of which may require interaction of the wire withthe tube supplying treatment to the mask.

According to particular embodiments, a system including a flexible patchfor facilitating voice communication through a mask, the flexible patchincludes: A) a base that is substantially T-shaped and has a thicknessof between 49-401 μm, the base including a first width, a second width,and an adhesive portion for attaching the base to a mask, wherein thesecond width is greater than the first width; B) a flexible circuitoperatively connected to the base, the flexible circuit including: 1) apiezoelectric element, the piezoelectric element for detectingvibrations of the mask through the base and converting the vibrations todata; 2) an electronic filter including a high pass filter for filteringthe data to remove frequencies below about 300 Hz and a low pass filterfor filtering the data to remove frequencies above about 3,000 Hz; and3) at least one processor, the at least one processor: i) amplifies thedata; and ii) transmits the data to a speaker for broadcasting the dataas a representation of human voice; C) a flexible substrate elementoperatively attached to the base and covering the flexible circuit forprotecting the flexible circuit from outside interference; and D) a waxpaper layer covering the adhesive portion of the base and sized suchthat at least a portion of the wax paper layer extends beyond an edge ofthe base.

In particular embodiments, the system herein, wherein the flexiblesubstrate element covers at least a portion of the base. In at least oneembodiment, the system herein, wherein the flexible circuit isoperatively connected to a power source. In some embodiments, the systemherein, wherein the piezoelectric element converts the vibrations toanalog data. According to one or more embodiments, the system herein,wherein the system includes an analog to digital converter forconverting the analog data to digital data. According to someembodiments, the system herein, wherein the system includes a digitalsignal processor, the digital signal processor for manipulating thedigital data prior to the digital data being transmitted to the speaker.In a particular embodiment, the system herein, wherein the digitalsignal processor is wirelessly connected to the flexible circuit.

According to one or more aspects, the system including a flexible patchfor facilitating voice communication through a mask including: A) a basehaving a thickness of between 49-401 μm and including a first width, asecond width, and an adhesive portion for attaching the base to a mask,wherein the second width is equal to or greater than the first width andthe base is operatively connected to a flexible circuit; B) apiezoelectric element operatively connected to the flexible circuit, thepiezoelectric element for detecting vibrations of the mask through thebase and converting the vibrations to data; C) a flexible substrateelement operatively attached to the base and covering at least a portionof the base, the flexible circuit, and the piezoelectric element forprotecting the flexible circuit and the piezoelectric element fromoutside interference; D) a removable wax paper layer covering theadhesive portion of the base and sized such that at least a portion ofthe wax paper layer extends beyond an edge of the base; E) an electronicfilter operatively connected to the flexible circuit, wherein theelectronic filter filters the data to remove frequencies below about 300Hz and above about 3,000 Hz; and F) at least one processor, the at leastone processor: 1) amplifies the data; and 2) transmits the data to aspeaker for broadcasting the data as a representation of human voice.

In at least one aspect, the system herein, wherein the piezoelectricelement is integrated with the flexible circuit. In some aspects, thesystem herein, wherein the at least one processor is operativelyconnected to the flexible circuit via a wire. In one or more aspects,the system herein, wherein the at least one processor is integrated withthe flexible circuit. In some aspects, the system herein, wherein thebase is substantially T-shaped. In at least one aspect, the systemherein, wherein the piezoelectric element converts the vibrations toanalog data. In various aspects, the system herein, wherein the systemincludes an analog to digital converter for converting the analog datato digital data. In certain aspects, the system herein, wherein the atleast one processor is operatively connected to the flexible circuit viaa wireless radio. In one or more aspects, the system herein, wherein thewireless radio includes a Bluetooth device. In some aspects, the systemherein, wherein the wireless radio is operatively connected to an alarm.In one or more aspects, the system herein, wherein the system includes aband pass filter for filtering the digital data. In at least one aspect,the system herein, wherein the band pass filter includes a high passfilter and a low pass filter. In various aspects, the system herein,wherein the high pass filter and low pass filter the digital data toremove frequencies below about 350 Hz and above about 2,500 Hz.

According to particular embodiments, a flexible patch for facilitatingvoice communication through a mask, the flexible patch including: A) abase including: 1) a piezoelectric element, the piezoelectric elementfor detecting vibrations of a mask and converting the vibrations todata; 2) at least one flexible substrate layer for protecting thepiezoelectric element from outside interference; B) a wiring enclosureattached to the flexible substrate layer via a flexible substrateadhesive layer; and at least partially enclosing: 1) the piezoelectricelement; and 2) one or more wires connecting an audio jack and thepiezoelectric element, wherein the flexible substrate layer compressesone or more edges of the piezoelectric element via the wiring enclosure,thereby increasing sensitivity of the piezoelectric element.

In one or more aspects, the flexible patch herein, wherein the basefurther includes an attachment adhesive layer for attaching the base tothe mask. In certain aspects, the flexible patch herein, wherein theflexible patch is substantially T-shaped. In certain aspects, theflexible patch herein, wherein the audio jack is for connecting theflexible patch to one or more speaker/receiver systems. In some aspects,the flexible patch herein, wherein the one or more speaker/receiversystems includes one or more capacitors to compensate for the increasedsensitivity of the piezoelectric element due to the compression of oneor more edges of the piezoelectric element. In particular aspects, theflexible patch herein, wherein the base further includes a foam layerfor protecting the piezoelectric element.

According to various embodiments, a disposable patch for facilitatingvoice communication through a mask, the disposable patch including: A)an attachment adhesive layer for attaching to a mask and adhered to afoam layer; B) the foam layer for protecting a piezoelectric element andadhered to a wiring sheath via a foam adhesive layer; C) thepiezoelectric element at least partially enclosed within the wiringsheath for detecting vibrations of the mask and converting thevibrations to data; D) the wiring sheath for at least partiallyenclosing the piezoelectric element and wiring connecting thepiezoelectric element to an audio jack and compressing one or more edgesof the piezoelectric element, thereby increasing sensitivity of thepiezoelectric element; and E) a flexible substrate layer adhered to thewiring sheath for protecting the piezoelectric element from outsideinterference.

In at least one aspect, the disposable patch herein, wherein thedisposable patch further includes a plastic shield layer attached to theattachment adhesive layer for preserving the attachment adhesive layeruntil the flexible patch is to be attached to the mask. In some aspects,the disposable patch herein, wherein the audio jack is for connectingthe flexible patch to one or more speaker/receiver systems.

According to one or more aspects, a system for facilitating voicecommunication through a mask including: A) at least one layer forprotecting a piezoelectric element and adhered to a wiring sheath via anadhesive layer; B) the piezoelectric element at least partially enclosedwithin the wiring sheath for detecting vibrations of a mask andconverting the vibrations to data; C) the wiring sheath for at leastpartially enclosing the piezoelectric element and wiring connecting thepiezoelectric element to a data transmitter, protecting thepiezoelectric element from outside interference, and compressing one ormore edges of the piezoelectric element, thereby increasing sensitivityof the piezoelectric element; and D) a speaker for broadcasting the dataas a representation of human voice.

In certain aspects, the system herein, wherein the piezoelectric elementis integrated with a flexible circuit at least partially enclosed withinthe wiring sheath. In at least one aspect, the system herein, whereinthe mask further includes a flexible substrate layer adhered to thewiring sheath for protecting the piezoelectric element from outsideinterference. In particular aspects, the system herein, wherein thesystem includes a speaker system for receiving the data from thepiezoelectric element via the data transmitter. In various aspects, thesystem herein, wherein the speaker system includes an amplifier. In oneor more aspects, the system herein, wherein a digital element isoperatively connected to the piezoelectric element via the datatransmitter. In some aspects, the system herein, wherein the datatransmitter includes a Bluetooth device. In particular aspects, thesystem herein, wherein the digital element is the amplifier and anelectronic filter and at least one processor amplifies and filters thedigital data. In certain aspects, the system herein, wherein the digitalelement filters the digital data to remove frequencies below about 350Hz and above about 2,500 Hz.

These and other aspects, features, and benefits of the claimedinvention(s) will become apparent from the following detailed writtendescription of the preferred embodiments and aspects taken inconjunction with the following drawings, although variations andmodifications thereto may be effected without departing from the spiritand scope of the novel concepts of the disclosure.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings illustrate one or more embodiments and/oraspects of the disclosure and, together with the written description,serve to explain the principles of the disclosure. Wherever possible,the same reference numbers are used throughout the drawings to refer tothe same or like elements of an embodiment, and wherein:

FIG. 1 illustrates an exemplary system environment, according to oneembodiment of the present disclosure.

FIG. 2 illustrates an exemplary system component diagram, according toone embodiment of the present disclosure

FIG. 3A is a side view of an exemplary method of attaching apiezoelectric element to a mask, according to one embodiment of thepresent disclosure.

FIG. 3B is a side view of an exemplary method of attaching apiezoelectric element to a mask, according to one embodiment of thepresent disclosure.

FIG. 3C is a side view of an exemplary method of attaching apiezoelectric element to a mask, according to one embodiment of thepresent disclosure.

FIG. 4A is a front view of an exemplary patch without a microphoneattached, according to one embodiment of the present disclosure.

FIG. 4B is a front view of an exemplary patch with a microphoneattached, according to one embodiment of the present disclosure.

FIG. 4C is a front view of an exemplary patch with a microphoneattached, according to one embodiment of the present disclosure

FIG. 5A is a front view of an alternate exemplary patch, according toone embodiment of the present disclosure.

FIG. 5B is a side view of an alternate exemplary patch, according to oneembodiment of the present disclosure.

FIG. 5C is an exploded view of an alternate exemplary patch, accordingto one embodiment of the present disclosure.

FIG. 5D is a front view of an additional alternate exemplary patch,according to one embodiment of the present disclosure.

FIG. 6A is an exemplary wireless connectivity diagram, according to oneembodiment of the present disclosure.

FIG. 6B is an alternate exemplary wireless connectivity diagram,according to one embodiment of the present disclosure

FIG. 7 is an exemplary recording and alarm feature diagram, according toone embodiment of the present disclosure.

FIG. 8 is a side view of an exemplary wire to tube attachment, accordingto one embodiment of the present disclosure.

FIG. 9 is a top perspective view of an exemplary patch, according to oneembodiment of the present disclosure.

FIG. 10 is a left side view of an exemplary patch, according to oneembodiment of the present disclosure.

FIG. 11 is a cross-sectional view of an exemplary patch, according toone embodiment of the present disclosure.

FIG. 12 is a front view of an exemplary patch, according to oneembodiment of the present disclosure.

FIG. 13 is a rear view of an exemplary patch, according to oneembodiment of the present disclosure.

FIG. 14 is a top view of an exemplary patch, according to one embodimentof the present disclosure.

FIG. 15 is a bottom view of an exemplary patch, according to oneembodiment of the present disclosure.

DETAILED DESCRIPTION

For the purpose of promoting an understanding of the principles of thepresent disclosure, reference will now be made to the embodimentsillustrated in the drawings and specific language will be used todescribe the same. It will, nevertheless, be understood that nolimitation of the scope of the disclosure is thereby intended; anyalterations and further modifications of the described or illustratedembodiments, and any further applications of the principles of thedisclosure as illustrated therein are contemplated as would normallyoccur to one skilled in the art to which the disclosure relates. Alllimitations of scope should be determined in accordance with and asexpressed in the claims.

Whether a term is capitalized is not considered definitive or limitingof the meaning of a term. As used in this document, a capitalized termshall have the same meaning as an uncapitalized term, unless the contextof the usage specifically indicates that a more restrictive meaning forthe capitalized term is intended. However, the capitalization or lackthereof within the remainder of this document is not intended to benecessarily limiting unless the context clearly indicates that suchlimitation is intended.

Overview

Aspects of the present disclosure generally relate to a system forcommunicating through a hard plastic mask, and more particularly tosystems and methods for recognizing speech vibrations throughCPAP/BiPAP® masks, filtering out non-human voice related noise, andoutputting the resulting speech of the mask wearer. In variousembodiments, the system includes a patch, the patch including a flexiblecircuit operatively connected to a vibrational energy transducer (e.g.,piezoelectric transducer) to receive voice input from humans.

In certain embodiments, the system includes a signal filtration systemto separate human voice from noise. In some embodiments, the signalfiltration system includes a low pass filter. In particular embodiments,the signal filtration system includes a high pass filter. In at leastone embodiment, the signal filtration system includes ananalog-to-digital converter. In one or more embodiments, the signalfiltration system includes a digital signal processor. In someembodiments, the flexible circuit includes an amplification unit forincreased intelligibility.

Additionally, according to at least one embodiment, the system includesa power source for providing power to the different system components.In at least one embodiment, the system includes a flexible substrate(e.g., tape) for encasing the microphone element and, in someembodiments, the flexible circuit. In one embodiment, the systemincludes a plastic housing for encasing the microphone (e.g.,piezoelectric) element.

In certain embodiments, the patch includes wires for operativelyconnecting the different system components, including, for example, theflexible circuit and/or microphone element to other portions of thesystem. In particular embodiments, the wires may be attached to a masktube that supplies a patient with oxygen and medicine. In someembodiments, the wires may be attached to the mask tube with anadhesive.

Furthermore, in various embodiments, aspects of the present disclosureare related to a mechanism for outputting discernable human voice. Insome embodiments, the output mechanism is a speaker or audio jack (e.g.,for connecting headphones, a speaker, or the like). In particularembodiments, the output mechanism is a wireless radio connection, suchas a Bluetooth device. In one embodiment, the output mechanism includesa calibration device to detect key words. In at least one embodiment,the calibration device includes a microprocessor to facilitateidentification and separation of key words. In various embodiments, thesystem includes an alarm for providing notification when a key word isdetected.

Exemplary Embodiments

Turning now to FIG. 1, an exemplary system environment 100 is shown,according to one embodiment of the present disclosure. In particularembodiments, and as mentioned briefly above, the exemplary systemenvironment includes a patch 104 for converting vibrational energy intoan AC electrical signal. In some embodiments, and as will be furtherdescribed herein, the patch 104 is attached to the outside of aCPAP/BiPAP® mask 102. In particular embodiments, the patch 104 isattached to the inside of the CPAP/BiPAP® mask. In at least oneembodiment, the patch 104 is embedded within the CPAP/BiPAP® mask 102.As will be understood from discussions herein, the patch 104 may includea microphone element, a flexible circuit, and various other componentsfor converting vibrations (e.g., human voice behind the mask) to speech.

According to various aspects of the present disclosure, the exemplarysystem environment 100 includes an amplification unit 110 (also referredto herein as “amplifier”) operatively connected to the patch 104 via awire 112. In particular embodiments, the wire may be between 8 gaugesand 20 gauges, or any other suitable size. In some embodiments, the wire112 is a triplex wire. In another embodiment, the wire 112 may be a mainfeeder wire, a panel feed wire, a single strand wire, a non-metallicsheathed wire, or any other suitable type of wire. In at least oneembodiment, the system is configured wirelessly and does not include awire 112.

In particular embodiments, the exemplary system environment 100 includesa power source 106 operatively connected to the system via a wire 108 togenerate the necessary current to power various components of thesystem. In various embodiments, the power source 106 may be batterypower. In certain embodiments, the power source may be outlet power. Inthese embodiments, the device may require additional conditioning ofpower to convert from AC/DC power and optimize the voltage. In theseembodiments, the AC current is changed to DC current using a powersupply AC/DC converter. In at least one embodiment, the power source 106may be both battery power and outlet power.

According to particular embodiments, a −5V voltage regulator is used inorder to obtain a 0V bias on the piezoelectric element, by applying the−5V offset to the system. This may allow the piezoelectric element's ACsignal to be measured and amplified by the system without floating theelement at a positive voltage. In some embodiments, the voltage of theoffset is dependent on the power supply of the system, which isdependent on the voltage required by the integrated circuits. As will beunderstood, the voltages may not need to be equal and opposite.

Turning now to FIG. 2, an exemplary system component diagram is shown,according to one embodiment of the present disclosure. The exemplarydiagram begins at step 202 where the system receives a vibration signal.The system is configured to receive a vibration signal from any suitablemechanism of communication, including but not limited to, human voicecommunication.

In one embodiment, a wire carries an signal (e.g., data) from apiezoelectric transducer (included with the patch 104 in FIG. 1), to afiltration system. In this embodiment, the filtration system uses aseries of integrated circuits or a processor to create one or morebandwidth filters. Generally, in at least one embodiment, the system isconfigured to remove frequencies outside of the frequency range of atypically human voice (e.g., to isolate frequencies within the humanvoice frequency range). As will be understood, the human voiceordinarily has a long term frequency range between about 250 Hz to 4,000Hz. In various embodiments, the system is configured to receive andprocess signals between about 10 Hz and 20,000 Hz and to filter outfrequencies above or below a typical human voice range (e.g.,approximately 250 Hz to 4,000 Hz).

For example, and as shown in FIG. 2, at step 202 the system receives avibration signal, such as a high profile noise found at about 5,000 Hz.At step 204, the vibration signal received at step 202 passes through aninitial bandpass filter. As will be understood, a bandpass filterincludes a high noise filter and a low noise filter. Continuing with thecurrent example, the bandpass filter may be used to filter out any noisebelow about 250 and 500 Hz. At step 206, the vibration signal passesthrough another bandpass filter such that any noise above about 2,000and 4,000 Hz is filtered out of the system and distinguishable speechcan still be output without noise.

In various embodiments, the filtration ranges may be reversed such thatthe first filter removes noise above about 2,000 and 4,000 Hz, and thesecond filter removes noise below about 250 and 500 Hz. In at least oneembodiment, the combination of bandpass filters provides frequencycutoffs at 300 Hz and 3,000 Hz with a slope of at least 40 DB/decade. Inparticular embodiments, due to the design of the filters there is aninherent gain of the signal from 10×-100× per filtration stage.

In some embodiments (not shown), if high noise is found in the lowerfrequency ranges (where wind noise is commonly found), the higherfrequency noises can be removed using up to a 250 Hz-500 Hz cutofffrequency bandpass filter, which may allow for a higher amplification ofthe low frequency voice elements, as the low frequency filtration systemwill have less high noise to filter out. In one embodiment, a 1,000 Hzto 1,500 Hz bandpass filters may be used. In another embodiment, a 2,500Hz to 3,000 Hz bandpass filter may be used.

As will be understood from discussions herein, the system may includedigital or analog filtering (or amplifying) components. In one or moreembodiments, the system include a series of bandpass filters asdiscussed above (e.g., for filtering analog data). In at least oneembodiment, the system includes a digital element/circuit (which may ormay not include a processor) for filtering and/or amplifying digitaldata. In further embodiments, the system includes an electrical circuitfor amplifying analog data (e.g., the amplifier is a physicalcomponent). In still further embodiments, the system includes at leastone processor for amplifying digital data (e.g., the amplifier andamplification functionality is carried out by at least one processor).

Continuing with FIG. 2, at step 208 the system outputs the filteredsignal. In various embodiments, the system may output the filteredsignal wirelessly (e.g., Bluetooth, Wi-Fi, ZigBee etc.). According toparticular embodiments, the system outputs the filtered signal via awired connection.

In some embodiments, the system is configured to amplify the filteredsignal, where the amplification of the signal is dependent on thequality of speaker that is used. As will be understood, while there is aminimum amplification to gain the raw signal from 25-50 mV to thestandard 2.89 V, additional amplification may be employed to overcomespeaker woofer inadequacies.

In particular embodiments (not shown), the system includes three stagesof integrated circuits, two of which have a fixed gain and whose mainpurpose is to filter the signal. In these embodiments, the thirdintegrated circuit is used in combination with a potentiometer to createa variable gain and to control the volume of the audio output. In someembodiments, the output of the circuit has two audio outputs: one to abuilt-in loudspeaker, and another to an output for allowing externalsound systems to accept the output audio signal such that the signal canbe shared and heard via multiple devices. In particular embodiments,this portion of the circuitry can be completed in a single stage bycombining it into a single stage bandpass filter with a variable gain.In some embodiments, the device can also be made with multiple stages,with redundant filtering to improve the slope and character of thefilters.

Referring now to FIG. 3 (including FIGS. 3A-3C), side views of exemplarymethods of attaching a patch (e.g., patch 104 shown in FIG. 1) to a mask102 are shown, according to one embodiment of the present disclosure. Invarious embodiments, the patch, including microphone element (e.g., thepiezoelectric transducer) 302, can be attached to the mask 102 by manydifferent methods. In some embodiments, the only limiting factor is thatthe face of the microphone element 302 should create sufficient contactwith the material of the mask 102 to receive vibrations when a personwearing the mask speaks.

In the embodiment shown in FIG. 3A, the system 301 includes a patch,including a microphone element 302 attached to a mask 102 via a flexiblesingle-sided adhesive system that houses the microphone element so thatthe patch is adhered to the mask 102. In this embodiment, contact ismade between the microphone element and the mask surface. In theseembodiments, a housing (e.g., flexible substrate) of the patch 302insulates the exterior connections of the microphone element, protectsthe microphone element 302 from unnecessary mechanical stresses thatwould put the microphone element at risk, and gives a mechanism ofattaching the microphone element to the mask 102.

Continuing with FIG. 3A, in a first embodiment, the patch includes twopieces of single sided tape where adhesive sides of the tape face thesame direction and sandwich the microphone element between the twopieces of single-sided tape, so the signal accepting side of themicrophone element faces the side of the system where the adhesive facesoutwards. In this first embodiment, the adhesive side of the tape systemwill then be used to attach the microphone element to the mask 102. Inthis embodiment, wire(s) 304 run from the signal output side of themicrophone element.

In a second embodiment, the system includes Kapton®, and there is asolder spot to allow wires 304 to easily attach to the Kapton® portionof the system to carry the microphone element signal from the microphoneelement to the other parts of the system. In these embodiments, theadhesive side of the Kapton® includes concentric circles terminals,where one concentric circle is positive and the other is negative. Inthis embodiment, a piezoelectric transducer with an exposed circularbrass ring is attached to these terminals with the signal receiving sidefacing outwards.

In particular embodiments, the patch 302 includes a flexible circuitthat can be made either by traditional flex printed circuit board (PCB)methods or by a less traditional layering method. In some embodiments,the layering method involves a four layer system. In this embodiment(and others), the first layer attaches directly to the mask 102 and thefourth layer is the farthest away from the mask 102. Continuing withthis embodiment, the first layer is a Kapton® film with a hole at leastthe diameter of the microphone element. The second layer, in thisembodiment, is a single side of conductor coated Kapton® layer with theconductor layer facing towards the first layer. Continuing with thisembodiment, the second layer defines an opening that is at least thediameter of the inner diameter of exposed brass on the microphoneelement, and at most equal to the outer diameter of the element. In thisembodiment, the third layer is made of a Kapton® film, which may or maynot have a solder-phobic coating to ensure separation of the positiveand negative connections made to the microphone element. This layer mayhave a hole that is about the diameter of the ceramic center of themicrophone element. Further continuing with this embodiment, the fourthlayer is made of a conductor coated Kapton® sheet with no hole. As willbe understood from discussions herein, the second layer and fourthlayer, in this embodiment, act as the negative and positive terminals(e.g., there is one positive and one negative terminal).

Further, in the embodiment discussed above (and others), the series ofholes in the Kapton® layers are concentric, but do not necessarily needto be circular just as long as the profile of the holes creates a clearpositive and negative connection with the microphone element with anarea of segregation. Continuing with this embodiment, the microphoneelement is adhered to the layers in the series of holes, with the signalreceiving side facing outward, and the copper sheets carrying the signalto terminals of a wire 304.

In the embodiment shown in FIG. 3B, the system 303 includes a contactarea of a microphone element that is permanently attached to a maskusing a high viscosity adhesive 306, such as an epoxy, to completelyincase the microphone. In these embodiments, the adhesive 306 is hardenough to transmit vibration (e.g. epoxy putty, two stage epoxy, singlestage epoxy, polyurethanes, emulsion adhesives). In at least oneembodiment, the mask and microphone assembly is produced as a singleunit.

In the embodiment shown in FIG. 3C, the system 305 includes a patch(e.g., including a piezoelectric transducer and a flexible circuit) 302encased in a mask 102, either by post-manufacturing modification orduring the molding of the mask. In these embodiments, the system doesnot include adhesives or the like.

In one embodiment, the patch 302 is suspended in the material of themask parallel or near parallel to the surface of the material. In atleast one embodiment, the material of the mask is silicone. Inparticular embodiments, a circular recessed area is designed in eitherthe mold of the mask 102 or is added via post processing into the mask,and is at least the diameter and the thickness of the patch 302. In thisembodiment, the microphone is placed in the recessed area. In variousembodiments, the leads of the patch 302 protrude from the convex side ofthe mask 102.

FIG. 4 (including FIGS. 4A-4C) shows front views of exemplary patches,according to one embodiment of the present disclosure. Generally, FIG.4A includes a front view of a patch without a microphone attached, FIG.4B includes a front view of a patch with a microphone attached, and FIG.4C includes a front view of a patch with a microphone attached showingthe connections between the microphone and the flexible circuit.

In particular embodiments, the patch 402 has a base with a width between10 mm and 50 mm, a height between 12 mm and 100 mm, and a thicknessbetween 50 μm and 400 μm. In one embodiment, the patch has a width ofapproximately 20 mm, a height of approximately 35 mm, and a thickness ofapproximately 50 μm. In another embodiment, the patch has a width ofapproximately 30 mm, a height of approximately 50 mm, and thickness ofapproximately 200 μm. In yet another embodiment, the patch 402 has awidth of approximately 50 mm, a height of approximately 100 mm, andthickness of approximately 400 μm. In various embodiments, the patch hasa width greater than 50 mm. In some embodiments, the patch has a widthless than 10 mm. In particular embodiments, the patch 402 has athickness greater than 400 μm. In at least one embodiment, the patch hasa thickness less than 50 μm.

In various embodiments, the patch 402 is T-shaped. In some embodiments,the patch is rectangular in shape. In particular embodiments, the patchmay be circular, or any other suitable shape. In at least oneembodiment, the patch 402 is I-shaped, such that the upper horizontalregion 403 is substantially wider than the lower horizontal region 407and the upper horizontal region may include a microphone element. Inthese embodiments, a vertical region 405 is included between the upperhorizontal region 403 and lower horizontal region 407, such that thevertical region 405 is substantially more narrow than the upper andlower horizontal regions. These embodiments allow the patch to maintainmaximum contact with a mask, and provide greater stability and loaddistribution when attached to a mask. In certain embodiments, a bottomhorizontal region 409 is included below the lower horizontal region 407that may provide additional support for cabling extended below andbeyond the patch.

In the embodiment shown in FIG. 4A, outputs of at least positive,negative, and ground are available for wires to carry a signal from themicrophone to an amplifier unit. In some embodiments, a flexible circuit401 includes a circular pattern of adhesive and conductors 414, or acircular pattern of conductive adhesive. In these embodiments, eitherpattern is connected by conductive pathways 410 through the verticalportion 405 to the positive or negative terminals 408. In particularembodiments, a conductive adhesive, conductive terminal, or acombination of conductive adhesive and a conductive terminal, is withinthe area of the circle of conduction 414 described above. In theseembodiments, the conductive terminal is connected via a flexibleconductive pathway 410 to the positive or negative output 408.

In the embodiment shown in FIG. 4B, a microphone element (e.g.,piezoelectric element) 412 is attached to the flexible circuit. In thisembodiment, the system includes a wiring enclosure 404, which, in someembodiments, is coated on the underside with adhesive, and containswiring with leads 406 protruding out from the assembly for connectingthe microphone element (e.g., piezoelectric element) 412 to externalequipment (e.g., speaker, audio jack, monitor, etc.).

FIG. 4C shows a front view of an exemplary patch 402 with apiezoelectric element attached to the flexible circuit 401, according toone embodiment of the present disclosure. In the embodiment shown, atransparent piezoelectric element is connected to the flexible circuit401, such that the underlying components are shown. In this embodiment,the underlying components include a circular pattern of adhesive andconductors 414 connected to a positive or negative output 408 via aconductive pathway 410.

According to at least one embodiment (not shown), the system includes aflexible substrate (e.g., tape) or plastic housing, or similar plasticmold, for housing the microphone (e.g., piezoelectric) element. In thisembodiment, the piezoelectric element is installed either pressed upagainst the inner wall closest to the signal source, or has an openingwhere the element can create direct contact with the signal source.

In certain embodiments (not shown), a flexible adhesive sleeve is usedto house the microphone (e.g., piezoelectric) element. In theseembodiments, the microphone element is housed between two sheets of thinflexible polymers with adhesive on at least one side. In particularembodiments, the adhesive adheres to the outside of the mask and may beprotected until use by a protective non-adhesive sheet, including, butnot limited to, wax paper.

FIG. 5A illustrates a front view of an alternate exemplary patch 500,according to one embodiment of the present disclosure. In variousembodiments, a double-sided adhesive layer 504 (sometimes referred toherein as “base”) attaches the flexible circuit 508 (which, in someembodiments, includes a microphone element) to the mask using theoutside layer of adhesive. In particular embodiments, the double-sidedadhesive layer is T-shaped to facilitate a secure attachment to themask. In one embodiment, the double-sided adhesive layer is rectangularin shape. In another embodiment, the double-sided adhesive layer may becircular, or any other suitable shape. In these embodiments, the insidelayer of adhesive holds the flexible circuit 508 and the protectivelayer (not shown) in place. In various embodiments, wiring 506 isenclosed in a wiring sheath 507 and is connected to the flexible circuit508 to facilitate external connections. In at least one embodiment, thewiring sheath extends downward towards and beyond the substantiallyhorizontal portion of the T-shaped double-sided adhesive layer 504.

Continuing with the embodiment shown in FIG. 5A, a removable protectivelayer 502 is included at the bottom of the device 500 to protect thedouble-sided adhesive layer prior to the device being attached to amask. In various embodiments, the removable protective layer 502 is awax paper layer and is larger in size than the layer of double-sidedadhesive 504. In particular embodiments, the removable protective layer502 is substantially identical in size to the double-sided adhesivelayer. In at least one embodiment, the removable protective layer 502 iscut in substantially the same shape as the double-sided adhesive layer504. In some embodiments, the removable protective layer is in asubstantially different shape than the shape of the double-sidedadhesive layer.

Turning now to FIG. 5B, a side view of the alternate exemplary patch 500is shown, according to one embodiment of the present disclosure. Invarious embodiments, a protective layer 510 may be included to insulatethe flexible circuit (flexible circuit, microphone 508 and wiring 506)from outside interference, and to secure the wiring 506 and solderpoints in the event that a pulling force is applied to the wiring sheath507 or another part of the apparatus. In one embodiment, the protectivelayer 510 is substantially identical in size and shape to thedouble-sided adhesive layer 504 such that it may fit securely on top ofthe double-sided adhesive layer. In at least one embodiment, theprotective layer 510 may be formed from plastic or any suitablematerial. In a particular embodiment, the protective layer 510 mayinclude one or more recesses for receiving the flexible circuit 508,wiring 506, or other components of the system. In at least oneembodiment, the protective layer 510 includes a flexible substrate, suchas a form of tape.

FIG. 5C shows an exploded view of the alternate exemplary patch 500,illustrating the way in which various components are connected. In oneembodiment, FIG. 5C shows the protective layer 510, the circuitry 508,the wiring 506, and the wiring sheath 507. Additionally, FIG. 5Cdemonstrates the positioning of the double-sided adhesive layer 504 withrespect to the oversized removable protective layer 502. Generally, thenumber of elements (e.g., removable protective layer 502, flexiblecircuit 508, protective layer 510, etc.), orientation of those elements,and composition of those elements as shown in FIG. 5C are for exemplarypurposes only. As shown in FIG. 5C, the removable protective layer 502attaches to the double-sided adhesive layer 504, which attaches to theflexible circuit 508, which attaches to the wiring 506 enclosed inwiring sheath 507, which attaches to the protective layer 510. As shown,the flexible circuit 508, the wiring (including leads) 506, and at leasta portion of the wiring sheath 507 are enclosed between the protectivelayer 510 and the double-sided adhesive layer 504.

Now referring to FIG. 5D, a front view of an additional alternateexemplary patch 500 is shown, according to one embodiment of the presentdisclosure. In the embodiment shown, the wiring sheath 507 containingthe wires 506 and connected to the flexible circuit 508 extends alongand beyond the elongated vertical portion of the T-shaped double-sidedadhesive layer 504. In this embodiment, the orientation of the removableprotective layer 502 and the double-sided adhesive layer 504 facilitatealternate positioning of the device 500 on a hard plastic mask.Additionally, the orientation shown in this embodiment, allows for amore significant portion of the wiring sheath 507 containing the wires506 to be secured under the protective layer 510, which further reducesthe effects of stress placed on solder points by a pulled wiring sheath507.

FIG. 6 (including FIGS. 6A and 6B) shows an exemplary wirelessconnectivity diagram, according to one embodiment of the presentdisclosure. Generally, FIGS. 6A and 6B show the signal transmission froma microphone 606 through a filter assembly. In various embodiments, thesignal can be transmitted from the microphone 606 through the filterassembly in either a wired or wireless configuration. In particularembodiments, a wireless radio assembly includes an analog to digitalconverter 608, digital signal processor 610, Bluetooth transmitter 612,and battery 614 mounted on a mask 102 (e.g., a flexible circuit 508shown in FIGS. 5A-5D). In these embodiments (and others) as shown inFIG. 6A, the Bluetooth transmitter transmits the signal received fromthe microphone 606 wirelessly to the speaker unit 602. In theseembodiments, the signal may be filtered, amplified and converted fromanalog to digital prior to Bluetooth transmittal. In some embodiments,the Bluetooth transmitter 612 is class II strength allowing it to onlytransmit to a phone within a particular range (e.g., the same room) toavoid potential multiple device interference and privacy issues.

In the embodiment shown in FIG. 6B, the microphone signal receivedthrough a mask is digitally converted with an analog to digitalconverter 608, and passed to a Bluetooth transmitter 612 that may belocated on the mask (e.g., a flexible circuit 508). In this embodiment,the Bluetooth transmitter passes the digital signal to a Bluetoothreceiver 604 located on a smartphone or other external device.Continuing with this embodiment, the digital signal is then processedwith a digital signal processor 611 for signal manipulation (e.g.,encoding, decoding, controlling volume, etc.), and output through aspeaker 602 or other output device. In this embodiment, the digitalsignal processor 611 is not included on the mask to reduce load on thesystem and increase battery life.

Additionally, Bluetooth enabled aspects of the present system maysupport smartphone compatibility. The typical smartphone may need anadditional lightweight app in order to be used in a “slave” manner—codeenabling the smartphone to sustain a RFCOMM connection. As will beunderstood, the code binds the device to an available RFCOMM socket,accepts the connection, and then outputs the signal to the built inspeakers on the phone.

Turning now to FIG. 7, an exemplary recording and alarm feature diagramis shown, according to one embodiment of the present disclosure. Invarious embodiments, the system includes a microphone 702, an analog todigital converter 704, a microprocessor 706, and a Bluetooth transmitter710. In particular embodiments, the system includes a Bluetooth receiver714 and an alarm 716 in a remote monitoring area, such that a patient'sverbal cues can trigger the alarm 716 and garner the attention of amember of the medical staff.

In one embodiment, the analog to digital converter 704 is operativelyconnected to the microphone 702. In this embodiment, the signal receivedfrom the microphone is fed into the microprocessor 706. Themicroprocessor 706, in this embodiment, has a read mode, activated by atactile button on the device. In some embodiments, the read mode may beactivated by any other suitable method (e.g., switch, voice command,etc.).

In various embodiments, the read mode listens and logs certain key wordsspoken by a mask wearer (e.g., “help,” “hungry,” “pain,” etc.). Onceactivated, calibration 712 begins as the system is configured to listenfor the key words separated by a pause. In one embodiment, the pause isused by the microprocessor 706 to differentiate between items during thecalibration period 712. In various embodiments, the words said andrepeated in the calibration period 712 may be recorded and stored in alibrary that compares three second clips of signal received from themicrophone for similarities to items in the library. In someembodiments, the length of signal clips compared may be less than threeseconds. In particular embodiments, the length of signal clips comparedmay be greater than three seconds. In some embodiments, the length ofsignal clips compared is any suitable length between 1 and 10 seconds(e.g., 2 seconds, 1-4 seconds, 5 seconds, etc.).

In certain embodiments, the library may be located on the device or maybe located elsewhere (e.g., electronic medical records). In oneembodiment, if there is a similarity in the signal and library entries,the system is configured to detect a calibrated signal, and send awarning via Bluetooth class I transmitter 710 (which has a range of 100m) to a connected unit with a Bluetooth receiver 714 at a nurse stationdescribed herein, or other location. In at least one embodiment, thewarning triggers an alarm 716 to ring. In these embodiments, the systemis configured to continue to send this signal periodically, and thealarm 716 will continue to ring until a stop alarm button is pressed onthe device, or other indication is given.

In one example (not shown), a nurse station includes a box with aspeaker, light, and Bluetooth class I receiver, with capabilities toconnect to multiple devices through an array. Continuing with thisexample, the receiver is always on and listening (e.g., periodically),and when a signal comes in from one of the devices in a patient's room,the signal is played through the speaker. This signal can be an alarm, apatient's voice, flashing lights, or other signaling mechanism.Continuing with this example, an array of lights indicates whichBluetooth transmitter is sending the message, and from what room thealert signal is coming. In at least one embodiment, there may be adigital to analog converter from the Bluetooth transmitter to thespeaker to allow direct signal output.

Referring now to FIG. 8, a side view of an exemplary wire to tubeattachment is shown, according to one embodiment of the presentdisclosure. In embodiments where the system includes a wired connectionfrom the microphone to the other components of the system, it may beadvantageous to integrate the wire(s) 804 with tube(s) 802 coming off ofthe mask designed to supply a patient with oxygen or medicine. As such,in one embodiment, when a patient moves in their bed, the patient doesnot become tangled in the tube 802 and wire 804, potentially injuringthemselves.

In particular embodiments, the wire 804 may be encased in plastic oranother suitable material 806 (e.g., via lamination or the like). Inthese embodiments, the wire 804 may be operatively connected to the tube802 by adhesive, heat shrink, or other methods of attachment. In someembodiments, the system includes a double layer polymer tube where thewire 804 is integrated between the two polymer layers. In theseembodiments, the wire 804 will protrude from both ends: one with themicrophone assembly and the other with a connector meant to connect tothe speaker system.

In one embodiment (not shown), the microphone element is connected tothe tube by using at least one clip. In some embodiments, the clip issubstantially circular and approximately the size of the tube with a gapslightly smaller than the outer diameter of the tube so that the tubecan be snapped into the inner circle of the clip. In certainembodiments, there may be a divot or inscribed circle on the interior ofthe circle, or within the material of the clip with a similar diameterof the cross sectional area of the mechanism used to connect thepiezoelectric element to the amplifier. In particular embodiments, agroove or hole will be made on the inner arch of the clip for the wireto be permanently housed in. As will be understood from discussionsherein, in some embodiments, the wire will not be able to slidelaterally through the hole, so that the clip maintains a constantlocation on the wire.

According to one embodiment (not shown), the microphone element isconnected to the amplifier by housing the microphone in at least a onecompartment sleeve. In some embodiments, a sleeve will be made out ofwater tight, insulating material that can be easily cleaned, such as atype of smooth, thin plastic, or other like material. In particularembodiments, the sleeve may be cinched at both ends to ensure the endsof the sleeve remain at the end of the tube.

In yet another embodiment (not shown), the system may include a sleevethat has two compartments and runs the length of a typical CPAP/BiPAP®tube (e.g., approximately 6 feet). In this embodiment, the firstcompartment of the sleeve has approximately 150% the volume of theCPAP/BiPAP® tube, so that the tube can easily slide into the sleeve. Inone embodiment, the second compartment of the sleeve is approximatelyone inch in diameter, and houses the wire that runs from the mask to thefilter assembly. Additionally, according to at least one embodiment (notshown), wire is constructed in a helical shape to allow the wire to beintertwined with the tube.

Turning now to FIG. 9, a top perspective view of an exemplary patch 900is shown, according to one embodiment of the present disclosure. FIG. 9provides reference to the cross sectional view of FIG. 11 taken along aline 11-11 in the side view. In various embodiments, the exemplary patch900 includes a base 902. In at least one embodiment, and as shown inFIG. 9, the base may include one or more layers to facilitate thefunctionality described herein. In at least one embodiment, the baseincludes a removable plastic shield layer 908 for covering and/orprotecting a first adhesive layer (e.g., attachment adhesive layer) 906.In certain embodiments, the plastic shield layer 908 is removed prior toattaching the patch 900 to a mask. In various embodiments, the plasticshield layer 908 has a thickness between 250 μm and 1,500 μm.

In various embodiments, the attachment adhesive layer 906 may include anadhesive material to facilitate application of the patch 900 to a hardplastic mask. In certain embodiments, the attachment adhesive layer 906has a thickness between 250 μm and 1,500 μm. In at least one embodiment,the attachment adhesive layer 906 includes adhesive material on bothsides to facilitate attachment of the attachment adhesive layer 906 to afoam layer 912.

In one or more embodiments, the base 902 may include a foam layer 912.In these embodiments (and others), the foam layer 912 providesprotection for the internal components of the patch, including thecircuit and/or piezoelectric element. In certain embodiments, the foamlayer may be composed of plastic (e.g., polyethylene, closed-cellpolyethylene, vinyls, polystyrene, phenolics, silicones, celluloseacetate, urethanes, etc.) In various embodiments, the foam layer 912 isaffixed to the attachment adhesive layer 906 on one side and a secondadhesive layer (e.g., foam adhesive layer) on the opposite side (as willbe discussed in relation to FIG. 11). In some embodiments, the foamlayer 912 has a thickness between 500 μm and 2,000 μm.

In some embodiments, the foam layer 912 is flexible allowing the patchto bend and conform to a surface (which may be curved) upon which it isattached. In particular embodiments, the foam layer 912 may haveductility between 105 percent and 125 percent. In addition, in someembodiments, the foam layer 912 protects electronics and circuitryincluded in the patch (as further discussed herein) by providinginsulation and a barrier for the electrical components when the patch900 is handled by users.

In particular embodiments, the patch 900 includes a plasticcovering/flexible substrate layer 904 for protecting the underlyingpatch layers and the patch circuitry. In some embodiments, the plasticcovering/flexible substrate layer 904 may be manufactured from vinyl. Inone or more embodiments, the plastic covering/flexible substrate layer904 may be manufactured from any suitable plastic that achieves thefunctionality described herein (e.g., polyethylene, polystyrene,phenolics, silicones, cellulose acetate, urethanes, etc.). In theseembodiments (and others), the plastic covering layer 904 coversunderlying circuitry, which can result in an elevated surface 914.

In at least one embodiment, the patch circuitry includes circuitryand/or a sensor element (e.g., piezoelectric element, microphone,accelerometer, vibration sensor, etc.) for receiving vibrations througha plastic mask and/or other information regarding the use of a mask (orother object). In some embodiments, the patch 900 includes wiringenclosed by a wiring enclosure/plastic sheath 916 protruding from thebase 902 for connecting the circuitry and/or sensor element (e.g.,piezoelectric element) to external equipment (e.g., speaker, audio jack,monitor, Bluetooth transmitter, etc.).

FIG. 10 shows a left side view of an exemplary patch 900, according toone embodiment of the present disclosure. In various embodiments, thewiring enclosure 916 protecting the wiring of the patch 900 includes aflexible material. In particular embodiments, the wiring enclosure 916is constructed from plastic (e.g., Polyethylene, PolyethyleneTerephthalate (PET), High-Density Polyethylene (HDPE), PolyvinylChloride (PVC), Low-Density Polyethylene (LDPE), Polypropylene (PP),Polystyrene (PP), etc.). In at least one embodiment, the wiringenclosure 916 is constructed from rubber (e.g., natural rubber,thermoset elastomer, thermoplastic elastomer, etc.).

FIG. 11 shows a cross-sectional view of an exemplary patch 900,according to one embodiment of the present disclosure, illustrating thevarious layers of base 902. In various embodiments, the exemplary patch900 may include one or more layers to facilitate the functionalitydescribed herein. In the embodiment shown in FIG. 11, the exemplarypatch 900 includes nine layers:

1. Removable plastic shield layer 908 (bottom-most layer).

2. Attachment adhesive layer 906.

3. Foam layer 912.

4. Foam adhesive layer 922.

5. Bottom plastic sheath layer 916 b.

6. Piezoelectric element 920.

7. Top plastic sheath layer 916 a.

8. Third adhesive layer 924 (flexible substrate adhesive layer).

9. Plastic covering layer 904 (top-most layer).

In certain embodiments, and as described above in relation to FIG. 9,the bottom layer is a removable plastic shield layer 908 for protectingthe attachment adhesive layer 906. In at least one embodiment, thesecond layer up from the bottom is an attachment adhesive layer 906 forfacilitating attachment of the exemplary patch 900 to a hard plasticmask. In particular embodiments, the third layer up from the bottom isthe foam layer 912. As described above, in certain embodiments, the foamlayer 912 may provide protection for the piezoelectric element 920 andrelated patch circuitry. In one or more embodiments, and as will befurther described herein, the exemplary patch 900 may also include afoam adhesive layer 922 substantially on top of the foam layer 912 forfacilitating attachment of the wiring enclosure/plastic sheath 916 andtop layer, or plastic covering layer 904. In various embodiments, thefoam adhesive layer 922 may be manufactured any suitable material toachieve the functionality described herein. In one or more embodiments,the foam adhesive layer 922 may be rubber-based.

In particular embodiments, the wiring enclosure/plastic sheath 916encloses the piezoelectric element (or other circuitry/sensors) 920. Inat least one embodiment, and as shown as plastic sheath layers 916 a and916 b in FIG. 11, the wiring enclosure/plastic sheath 916 extends withinthe layers of the exemplary patch, substantially surrounding thepiezoelectric element 920. In particular embodiments, a bottom plasticsheath layer 916 b is attached to the foam layer 912 via foam adhesivelayer 922 and the top plastic sheath layer 916 a is attached to theplastic covering layer 904 via a third adhesive layer 924.

The wiring enclosure/plastic sheath 916 may fully or partially enclosethe piezoelectric element 920. In at least one embodiment, the wiringenclosure/plastic sheath 916 encloses the piezoelectric element 920other than a backside of the piezoelectric element 920, where wiresconnect the piezoelectric element 920 to the audio jack 926 through thewiring enclosure/plastic sheath 916. In some embodiments, the wiringenclosure/plastic sheath 916 encloses the piezoelectric element 920other than a front side and the backside of the piezoelectric element920 (e.g., the wiring enclosure/plastic sheath 916 substantiallyencloses a top and bottom and sides of the piezoelectric element 920).

In one or more embodiments, the plastic covering layer 904 compressesthe wiring enclosure/plastic sheath layers 916 a and 916 b, along withthe piezoelectric element 920. In some embodiments, wiringenclosure/plastic sheath layers 916 a and 916 b compress thepiezoelectric element 920. In various embodiments, the perpendicularcompression force of the plastic covering layer and/or the plasticsheath layers 916 a and 916 b (e.g., similar to shrink wrapping) isapplied to the piezoelectric element 920. In at least one embodiment,“edge compression” applied by the plastic covering layer (via wiringenclosure/plastic sheath layers 916 a and 916 b) or directly by thewiring enclosure/plastic sheath layers 916 a and 916 b creates anincreased sensitivity in the piezoelectric element 920, such that thepiezoelectric element 920 (e.g., microphone) amplification ischanged/increased (e.g., when compared to a piezoelectric elementwithout edge compression). In particular embodiments, the exertion ofthe edge compression on the piezoelectric element may facilitate anamplification gain between twenty percent and fifty percent. In certainembodiments, the amplification gain may provide for increasedsensitivity of the piezoelectric element, such that the piezoelectricelement may process broader frequency ranges and/or lower decibelsounds. In one or more embodiments, the amplification gain may alsoprovide for greater output levels.

In one or more embodiments, the plastic covering layer 904 provides aseal for the piezoelectric element 920 and other underlying components(e.g., foam layer 912). In various embodiments, the seal provided by theplastic covering layer 904 may be a vacuum seal, a heat seal, a clingseal, or any other sealing technique suitable to achieve thefunctionality described herein (such as, for example, edge compression).In certain embodiments, similar to shrink wrapping, sealing the plasticcovering layer 904 causes the plastic covering layer 904 to shrinktightly over the underlying layers. In various embodiments, once sealed,the plastic covering layer 904 exerts a perpendicular compression forceon the piezoelectric element 920 and other underlying components. Inparticular embodiments, this perpendicular compression force applied tothe piezoelectric element 920 facilitates the amplification gain asdescribed above.

In at least one embodiment, the patch 900 may include one or morecapacitors to regulate the sensitivity (e.g., amplification) generatedby the piezoelectric element 920. In certain embodiments, the one ormore capacitors may be included on the external output mechanism (e.g.,speaker). In some embodiments, the one or more capacitors may beincluded on both the patch 900 and the external output mechanism. Invarious embodiments, the one or more capacitors are configured to matchthe impedance (e.g., resistance) of the underlying patch 900 circuitry.As will be understood, the edge compression increases sensitivity of thepiezoelectric element 920 and it may be advantageous to provide one ormore capacitors to regulate amplification of the same and providenuanced control over outputs of the system (e.g., greater amplificationand the use of capacitors may provide more granular control/fine tuningof outputs, which might be useful for interpreting vibrations based on avarious vocal ranges). In particular embodiments, the amplification gainis regulated digitally.

In particular embodiments, the exemplary patch may include less thannine layers. In these embodiments (and others), the patch may include aremovable plastic shield layer, a foam layer, a piezoelectric element,and a plastic covering layer. In particular embodiments, the foam layermay include a double-sided adhesive. In at least one embodiment, theexemplary patch may include a plastic sheath (e.g., plastic sheath topand bottom layers), a piezoelectric element, and one or more adhesivelayers. In some embodiments, the exemplary patch includes any suitablenumber of layers and may or may not include foam layer.

Now referring to FIG. 12, a front view of an exemplary patch is shown,according to one embodiment of the present disclosure. In particularembodiments, the base 902 may include a plastic covering layer 904. Insome embodiments, the base may also include a foam adhesive layer 922,whereby the foam adhesive layer 922 is composed of adhesive material tofacilitate attachment of the foam adhesive layer 922 to the top side ofthe foam layer 912 and the bottom side of the plastic covering layer 904(the bottom side of the plastic covering layer 904 may also include athird adhesive layer 924, as shown in FIG. 11). In various embodiments,the foam adhesive layer 922 has a thickness between 250 μm and 1,500 μm.In particular embodiments, the plastic covering layer 904 may beconstructed of plastic (e.g., Polyethylene, Polyethylene Terephthalate(PET), High-Density Polyethylene (HDPE), Polyvinyl Chloride (PVC),Low-Density Polyethylene (LDPE), Polypropylene (PP), Polystyrene (PP),etc.). In at least one embodiment, the plastic covering layer 904 isconstructed of rubber (e.g., natural rubber, thermoset elastomer,thermoplastic elastomer, etc.). In certain embodiments, plastic coveringlayer 904 has a thickness between 250 μm and 1,500 μm.

FIG. 13 shows a rear view of an exemplary patch, according to oneembodiment of the present disclosure. In various embodiments, and asshown in FIG. 13, the patch 900 includes an audio jack 926 connected towiring wrapped in a wiring enclosure 916 protruding out from the base902. In one or more embodiments, and as discussed above, the wiringwrapped in a wiring enclosure 916 is connected to a microphone element920 at the end opposite the audio jack 926. In particular embodimentsthe audio jack 926 facilitates connection to an external speaker,receiver, or other suitable audio control device.

FIG. 14 shows a top view of an exemplary patch 900, according to oneembodiment of the present disclosure. In certain embodiments, the base902 of the patch 900 may be substantially rectangular in shape. Inparticular embodiments, the base 902 may be circular, triangular, or anyother suitable shape. In one or more embodiments, and as shown in FIG.13, the base 902 may include rounded edges.

Turning now to FIG. 15, a bottom view of an exemplary patch 900 isshown, according to one embodiment of the present disclosure. Inparticular embodiments, the underside of the base 902 may besubstantially smooth to facilitate application to a hard plastic mask.In certain embodiments, the wiring enclosure 916 may extend outwardbetween 5 mm and 25 mm from the base 902 of the patch 900. In variousembodiments, to facilitate the functionality described herein, thewiring enclosure 916 may extend outward up to 75 mm from the base 902 ofthe patch 900.

Additional Embodiments Patch Shape

As will be understood from discussions herein, the patch (e.g., base)may be any suitable shape. In various embodiments, the base issubstantially circular, substantially rectangular, substantiallytriangular, etc. In particular embodiments, the base of the patch issubstantially the size and shape of the flexible circuit and/orpiezoelectric element.

Uses as a Diagnostic Aid

In one embodiment, the disclosed device removes all frequencies exceptthe range of noises of respiratory noises. Respiratory noise frequencyrange may be contingent upon the persons spoken voice frequency range.In one embodiment, a calibration period would be necessary to obtain atleast information about the frequency range of the subject's normalspoken voice.

Location of the Speaker

The amplifier and/or speaker unit may be placed anywhere on the masktube machine interface (or external to the same). This includes, but isnot limited to, on the mask, on the tube, on the hospital bed, on theCPAP/BiPAP® machine, or integrated into the CPAP/oxygen machine.Further, as discussed herein, one or more of the other componentsdiscussed herein may be located remotely or otherwise in a differentphysical location than other components (e.g., in one example, the patchmay be disposable and may be operatively connected to an amplifier andspeaker system that are not physically located on the mask, such thatthe patch can be disposed of, but the amplifier and speaker (and othercomponents) can be reused). If on the machine, the speaker will beattached to the outside of the machine via hook, velcro, pouch, or othermeans of attachment. The location of the speaker includes, but is notlimited to, the top and sides of the machine, handles that are attachedto the machine, the stand/cart, or other apparatus that houses themachine.

If on the hospital bed, the speaker may be attached or integrated via,but not limited to, hook, pouch or velcro. Integration of the speakerincludes, but is not limited to, into the bed via manufacturing, audiocable, or through any form of wireless communication.

If on the mask, the speaker may be attached and/or integrated via, butnot limited to, buttons, velcro, and epoxy. The speaker may be mountedanywhere on the exterior of the mask.

As will be understood, any number of electronic components may belocated on a patch or on a separate speaker system. For example, in oneembodiment, the patch may include amplifiers, capacitors, etc., in someembodiments, the patch may include a piezoelectric element (only) andall additional circuitry is located at a separate speaker system.

Methods of Use

The present disclosure contemplates methods of using the systemsdescribed herein. According to at least one embodiment, an exemplarymethod includes providing: A) a substantially rectangular-shaped basehaving a thickness of between 500-5000 μm and including a first width, asecond width, and an adhesive portion for attaching the base to a mask,wherein the second width is greater than the first width; B) a flexiblecircuit operatively connected to the base, the flexible circuitincluding: C) a piezoelectric element, the piezoelectric element fordetecting vibrations of the mask through the base and converting thevibrations to data; D) an electronic filter including a high pass filterfor filtering the data to remove frequencies below about 300 Hz and alow pass filter for filtering the data to remove frequencies above about3,000 Hz; E) at least one processor, the at least one processor: i)amplifies the data; and ii) transmits the data to a speaker forbroadcasting the analog data as a representation of human voice; F) aflexible substrate element operatively attached to the base and coveringat least a portion of the base and the flexible circuit for protectingthe flexible circuit from outside interference; and G) a wax paper layercovering the adhesive portion of the base and sized such that at least aportion of the wax paper layer extends beyond an edge of the base.

According to at least one embodiment, an exemplary method includes: A)removing a wax paper layer covering an adhesive portion of asubstantially rectangular-shaped base having a thickness of between500-5000 μm, wherein the wax paper is sized such that at least a portionof the wax paper layer extends beyond an edge of the base; B) affixingthe substantially T-shaped base to a hard plastic mask, wherein: 1) thesubstantially T-shaped base is operatively connected to a flexiblecircuit including: i) a piezoelectric element, the piezoelectric elementfor detecting vibrations of the mask through the base and converting thevibrations to data; ii) an electronic filter including a high passfilter for filtering the data to remove frequencies below about 300 Hzand a low pass filter for filtering the data to remove frequencies aboveabout 3,000 Hz; and iii) at least one processor, the at least oneprocessor: a) amplifies the data; and b) transmits the data to a speakerfor broadcasting the analog data as a representation of human voice; and2) a flexible substrate element is operatively attached to the base andcovering at least a portion of the base and the flexible circuit forprotecting the flexible circuit from outside interference.

Sensors/Computing System

From the foregoing, it will be understood that various aspects of theprocesses described herein are software processes that execute oncomputer systems that form parts of the system. Accordingly, it will beunderstood that various embodiments of the system described herein aregenerally implemented as specially-configured computers includingvarious computer hardware components and, in many cases, significantadditional features as compared to conventional or known computers,processes, or the like, as discussed in greater detail herein.Embodiments within the scope of the present disclosure also includecomputer-readable media for carrying or having computer-executableinstructions or data structures stored thereon. Such computer-readablemedia can be any available media which can be accessed by a computer, ordownloadable through communication networks. By way of example, and notlimitation, such computer-readable media can include various forms ofdata storage devices or media such as RAM, ROM, flash memory, EEPROM,CD-ROM, DVD, or other optical disk storage, magnetic disk storage, solidstate drives (SSDs) or other data storage devices, any type of removablenonvolatile memories such as secure digital (SD), flash memory, memorystick, etc., or any other medium which can be used to carry or storecomputer program code in the form of computer-executable instructions ordata structures and which can be accessed by a computer.

When information is transferred or provided over a network or anothercommunications connection (either hardwired, wireless, or a combinationof hardwired or wireless) to a computer, the computer properly views theconnection as a computer-readable medium. Thus, any such a connection isproperly termed and considered a computer-readable medium. Combinationsof the above should also be included within the scope ofcomputer-readable media. Computer-executable instructions include, forexample, instructions and data which cause a computer to perform onespecific function or a group of functions.

Those skilled in the art will understand the features and aspects of asuitable computing environment in which aspects of the disclosure may beimplemented. Although not required, some of the embodiments of theclaimed inventions may be described in the context ofcomputer-executable instructions, such as program modules or engines, asdescribed earlier, being executed by computers in networkedenvironments. Such program modules are often reflected and illustratedby flow charts, sequence diagrams, exemplary screen displays, and othertechniques used by those skilled in the art to communicate how to makeand use such computer program modules. Generally, program modulesinclude routines, programs, functions, objects, components, datastructures, application programming interface (API) calls to othercomputers whether local or remote, etc. that perform particular tasks orimplement particular defined data types, within the computer.Computer-executable instructions, associated data structures and/orschemas, and program modules represent examples of the program code forexecuting steps of the methods disclosed herein. The particular sequenceof such executable instructions or associated data structures representexamples of corresponding acts for implementing the functions describedin such steps.

Those skilled in the art will also appreciate that the claimed and/ordescribed systems and methods may be practiced in network computingenvironments with many types of computer system configurations,including personal computers, smartphones, tablets, hand-held devices,multi-processor systems, microprocessor-based or programmable consumerelectronics, networked PCs, minicomputers, mainframe computers, and thelike. Embodiments of the claimed invention are practiced in distributedcomputing environments where tasks are performed by local and remoteprocessing devices that are linked (either by hardwired links, wirelesslinks, or by a combination of hardwired or wireless links) through acommunications network. In a distributed computing environment, programmodules may be located in both local and remote memory storage devices.

An exemplary system for implementing various aspects of the describedoperations, which is not illustrated, includes a computing deviceincluding a processing unit, a system memory, and a system bus thatcouples various system components including the system memory to theprocessing unit. The computer will typically include one or more datastorage devices for reading data from and writing data to. The datastorage devices provide nonvolatile storage of computer-executableinstructions, data structures, program modules, and other data for thecomputer.

Computer program code that implements the functionality described hereintypically includes one or more program modules that may be stored on adata storage device. This program code, as is known to those skilled inthe art, usually includes an operating system, one or more applicationprograms, other program modules, and program data. A user may entercommands and information into the computer through keyboard, touchscreen, pointing device, a script containing computer program codewritten in a scripting language or other input devices (not shown), suchas a microphone, etc. These and other input devices are often connectedto the processing unit through known electrical, optical, or wirelessconnections.

The computer that effects many aspects of the described processes willtypically operate in a networked environment using logical connectionsto one or more remote computers or data sources, which are describedfurther below. Remote computers may be another personal computer, aserver, a router, a network PC, a peer device or other common networknode, and typically include many or all of the elements described aboverelative to the main computer system in which the inventions areembodied. The logical connections between computers include a local areanetwork (LAN), a wide area network (WAN), virtual networks (WAN or LAN),and wireless LANs (WLAN) that are presented here by way of example andnot limitation. Such networking environments are commonplace inoffice-wide or enterprise-wide computer networks, intranets, and theInternet.

When used in a LAN or WLAN networking environment, a computer systemimplementing aspects of the invention is connected to the local networkthrough a network interface or adapter. When used in a WAN or WLANnetworking environment, the computer may include a modem, a wirelesslink, or other mechanisms for establishing communications over the widearea network, such as the Internet. In a networked environment, programmodules depicted relative to the computer, or portions thereof, may bestored in a remote data storage device. It will be appreciated that thenetwork connections described or shown are exemplary and othermechanisms of establishing communications over wide area networks or theInternet may be used.

CONCLUSION

While various aspects have been described in the context of a particularembodiments, additional aspects, features, and methodologies of theclaimed systems and methods will be readily discernible from thedescription herein, by those of ordinary skill in the art. Manyembodiments and adaptations of the disclosure and claimed systems andmethods other than those herein described, as well as many variations,modifications, and equivalent arrangements and methodologies, will beapparent from or reasonably suggested by the disclosure and theforegoing description thereof, without departing from the substance orscope of the claims. Furthermore, any sequence(s) and/or temporal orderof steps of various processes described and claimed herein are thoseconsidered to be the best mode contemplated for carrying out the claimedsystems and methods. It should also be understood that, although stepsof various processes may be shown and described as being in a preferredsequence or temporal order, the steps of any such processes are notlimited to being carried out in any particular sequence or order, absenta specific indication of such to achieve a particular intended result.In most cases, the steps of such processes may be carried out in avariety of different sequences and orders, while still falling withinthe scope of the claimed systems and methods. In addition, some stepsmay be carried out simultaneously, contemporaneously, or insynchronization with other steps.

The embodiments were chosen and described in order to explain theprinciples of the claimed systems and methods and their practicalapplication so as to enable others skilled in the art to utilize theinventions and various embodiments and with various modifications as aresuited to the particular use contemplated. Alternative embodiments willbecome apparent to those skilled in the art to which the claimed systemsand methods pertain without departing from their spirit and scope.Accordingly, the scope of the claimed systems and methods are defined bythe appended claims rather than the foregoing description and theexemplary embodiments described therein.

What is claimed is:
 1. A flexible patch for facilitating voicecommunication through a mask, the flexible patch comprising: a basecomprising: a piezoelectric element, the piezoelectric element fordetecting vibrations of a mask and converting the vibrations to data; atleast one flexible substrate layer for protecting the piezoelectricelement from outside interference; a wiring enclosure attached to theflexible substrate layer via a flexible substrate adhesive layer; and atleast partially enclosing: the piezoelectric element; and one or morewires connecting an audio jack and the piezoelectric element, whereinthe flexible substrate layer compresses one or more edges of thepiezoelectric element via the wiring enclosure, thereby increasingsensitivity of the piezoelectric element.
 2. The flexible patch of claim1, wherein the base further comprises an attachment adhesive layer forattaching the base to the mask.
 3. The flexible patch of claim 2,wherein the flexible patch is substantially T-shaped.
 4. The flexiblepatch of claim 1, wherein the audio jack is for connecting the flexiblepatch to one or more speaker/receiver systems.
 5. The flexible patch ofclaim 4, wherein the one or more speaker/receiver systems comprises oneor more capacitors to compensate for the increased sensitivity of thepiezoelectric element due to the compression of one or more edges of thepiezoelectric element.
 6. The flexible patch of claim 1, wherein thebase further comprises a foam layer for protecting the piezoelectricelement.
 7. A disposable patch for facilitating voice communicationthrough a mask, the disposable patch comprising: an attachment adhesivelayer for attaching to a mask and adhered to a foam layer; the foamlayer for protecting a piezoelectric element and adhered to a wiringsheath via a foam adhesive layer; the piezoelectric element at leastpartially enclosed within the wiring sheath for detecting vibrations ofthe mask and converting the vibrations to data; the wiring sheath for atleast partially enclosing the piezoelectric element and wiringconnecting the piezoelectric element to an audio jack and compressingone or more edges of the piezoelectric element, thereby increasingsensitivity of the piezoelectric element; and a flexible substrate layeradhered to the wiring sheath for protecting the piezoelectric elementfrom outside interference.
 8. The disposable patch of claim 7, whereinthe disposable patch further comprises a plastic shield layer attachedto the attachment adhesive layer for preserving the attachment adhesivelayer until the flexible patch is to be attached to the mask.
 9. Thedisposable patch of claim 7, wherein the audio jack is for connectingthe flexible patch to one or more speaker/receiver systems.
 10. A systemfor facilitating voice communication through a mask comprising: at leastone layer for protecting a piezoelectric element and adhered to a wiringsheath via an adhesive layer; the piezoelectric element at leastpartially enclosed within the wiring sheath for detecting vibrations ofa mask and converting the vibrations to data; the wiring sheath for atleast partially enclosing the piezoelectric element and wiringconnecting the piezoelectric element to a data transmitter, protectingthe piezoelectric element from outside interference, and compressing oneor more edges of the piezoelectric element, thereby increasingsensitivity of the piezoelectric element; and a speaker for broadcastingthe data as a representation of human voice.
 11. The system of claim 10,wherein the piezoelectric element is integrated with a flexible circuitat least partially enclosed within the wiring sheath.
 12. The system ofclaim 10, wherein the mask further comprises a flexible substrate layeradhered to the wiring sheath for protecting the piezoelectric elementfrom outside interference.
 13. The system of claim 12, wherein thepiezoelectric element converts the vibrations to analog data.
 14. Thesystem of claim 13, wherein the system comprises a speaker system forreceiving the data from the piezoelectric element via the datatransmitter.
 15. The system of claim 14, wherein the speaker systemcomprises an amplifier.
 16. The system of claim 15, wherein the systemcomprises an analog to digital converter for converting the analog datato digital data.
 17. The system of claim 16, wherein a digital elementis operatively connected to the piezoelectric element via the datatransmitter.
 18. The system of claim 17, wherein the data transmitterincludes a Bluetooth device.
 19. The system of claim 18, wherein thedigital element is the amplifier and an electronic filter and at leastone processor amplifies and filters the digital data.
 20. The system ofclaim 19, wherein the digital element filters the digital data to removefrequencies below about 350 Hz and above about 2,500 Hz.